[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645978":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":31,"studyPopulation":23,"armGroups":32,"interventions":43,"overallOfficials":23,"centralContacts":49,"locations":59,"responsibleParty":71,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":23,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":23,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":102,"overallStatus":106,"whyStopped":23,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Manouba","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Bone Mineral Density (BMD)","Bone mineral density (BMD) will be assessed using dual-energy X-ray absorptiometry (DXA) at baseline and after the 6-month intervention period. BMD measurements will be used to evaluate changes in bone health in response to the intervention in older adults.","Baseline and 6 months (pre-intervention and post-intervention)",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Gait performance","Gait performance will be assessed using a standardized 4-meter gait speed test at baseline and after the 6-month intervention period. Participants will be instructed to walk at their usual pace, and gait speed will be used as an indicator of functional mobility and physical performance in older adults.",{"measure":18,"description":19,"timeFrame":12},"Balance","Balance will be assessed using the Berg Balance Scale or a one-leg stance test at baseline and after the 6-month intervention period. These tests will evaluate static and dynamic balance ability in older adults and will be used to determine changes in postural stability following the intervention.",{"measure":21,"description":22,"timeFrame":12},"Fall Risk","Fall risk will be assessed using the Timed Up and Go (TUG) test at baseline and after the 6-month intervention period. The TUG test measures the time required to stand up from a chair, walk 3 meters, turn, return, and sit down, and is used as an indicator of functional mobility and fall risk in older adults.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to either an experimental group or a control group. The study will follow a parallel design, with both groups participating simultaneously over a 6-month intervention period. The experimental group will follow a 16:8 time-restricted eating and exercise protocol, while the control group will maintain their habitual dietary practices.","TREATMENT",{"masking":30,"maskingDescription":23,"whoMasked":23},"NONE","This randomized controlled trial is designed to evaluate the effects of Early Time-Restricted Eating (eTRE) combined with a multicomponent exercise program on bone mineral density, physical function, and fall risk in healthy older adults.\n\nParticipants will be randomly assigned in a 1:1 ratio to either an experimental group or a control group. The intervention will last for 6 months. The experimental group will follow an Early Time-Restricted Eating protocol, consisting of an 8-hour daily eating window (e.g., 07:00-15:00) followed by a 16-hour fasting period, in combination with a supervised multicomponent exercise program performed three times per week.\n\nEach exercise session will last approximately 60 minutes and will include resistance training, balance exercises, aerobic activities, and flexibility exercises. Exercise sessions will be scheduled within the eating window to optimize energy availability and recovery. Dietary intake will be monitored to ensure adequate energy and protein consumption.\n\nThe control group will maintain their usual lifestyle without any structured dietary timing or exercise intervention.\n\nAssessments will be conducted at baseline and after the intervention period. Data will be analyzed using repeated measures analysis to evaluate the effects of time, group, and their interaction on study outcomes.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Early Time-Restricted Eating (eTRE)+Exercise Intervention Group","EXPERIMENTAL","Participants in the experimental group will follow a 16:8 Early Time-Restricted Eating protocol combined with a supervised multicomponent exercise program for 6 months. The exercise program includes resistance, aerobic, balance, and flexibility training, while the eating window is restricted to 8 hours per day with adequate energy and protein intake maintained.",[38],"Behavioral: Early Time-Restricted Eating (eTRE)+Exercise Intervention",{"label":40,"type":41,"description":42,"interventionNames":23},"Control","NO_INTERVENTION","Participants in the control group will not receive any structured exercise program or dietary timing intervention and will be instructed to maintain their habitual diet and physical activity throughout the study period.",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":23},"BEHAVIORAL","Early Time-Restricted Eating (eTRE)+Exercise Intervention","Participants will follow an Early Time-Restricted Eating protocol consisting of a 16:8 fasting-feeding schedule. All daily caloric intake will be consumed within an 8-hour window (e.g., 07:00-15:00), followed by a 16-hour fasting period. Participants will be instructed to maintain adequate energy intake and consume at least 1.2 g\u002Fkg\u002Fday of protein, distributed across meals within the eating window. Water intake will be allowed ad libitum during fasting hours. A supervised multicomponent exercise program including resistance, aerobic, balance, and flexibility training. Sessions will be performed three times per week for 6 months. Resistance training will be performed at 60-80% of one-repetition maximum, aerobic training at moderate intensity (50-70% of maximum heart rate), and balance and flexibility exercises will be included in each session to improve functional capacity in older adults.",[34],[50,55],{"name":51,"role":52,"phone":53,"phoneExt":23,"email":54},"Maha Gasmi, PhD","CONTACT","+21699040701","mahagasmi@hotmail.fr",{"name":56,"role":52,"phone":57,"phoneExt":23,"email":58},"Kawther Missawi, PhD","+21697323721","kawther.missawi@hotmail.fr",[60],{"facility":61,"status":23,"city":62,"state":62,"zip":23,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":23},"Manouba University","Manouba","Tunisia","TN",{"type":66,"coordinates":67},"Point",[68,69],10.09557,36.81006,{"lat":69,"lon":68},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Maha Gasmi","Researcher",[76],{"name":77,"class":6},"Faculty of Medicine, Sousse","100645978","early-time-restricted-eating-combined-with-exercise-in-older-adults-100645978",false,"NCT07695961","Early Time-Restricted Eating Combined With Exercise in Older Adults","Effects of Early Time-Restricted Eating Combined With a Multicomponent Exercise Program on Bone Mineral Density, Gait, Balance, and Fall Risk in Healthy Older Adults: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 60 years or older\n* Community-dwelling and generally healthy older adults\n* Sedentary or moderately physically active\n* Stable body weight during the previous 3 months (no intentional weight loss or gain \\>5%)\n* Able to participate in a supervised exercise program\n* Willing to comply with the time-restricted eating protocol and study procedures\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosis of osteoporosis requiring pharmacological treatment\n* Severe sarcopenia or major mobility limitations preventing safe exercise participation\n* Cognitive impairment or diagnosed dementia affecting ability to follow instructions\n* Presence of uncontrolled chronic diseases affecting bone metabolism (e.g., advanced renal disease, uncontrolled endocrine disorders)\n* Current use of medications affecting bone metabolism (e.g., corticosteroids, anti-osteoporotic drugs)\n* Participation in another structured exercise or dietary intervention program within the past 3 months\n* Any medical condition that contraindicates moderate-intensity exercise\n* Inability to comply with study protocol or follow-up assessments",true,"ALL","60 Years","85 Years",{"count":90,"type":91},44,"ESTIMATED","INTERVENTIONAL",[94],"NA","This randomized controlled trial aims to investigate the effects of Early Time-Restricted Eating (eTRE) combined with a multicomponent exercise program on bone health, physical function, and fall risk in healthy older adults.\n\nA total of approximately 44 healthy adults aged 60 years and older will be recruited and randomly assigned to one of two groups. The experimental group will follow an Early Time-Restricted Eating schedule combined with a structured multicomponent exercise program. The control group will not receive any dietary timing intervention or structured exercise program and will continue their usual daily lifestyle.\n\nThe intervention will last for 6 months. Participants in the exercise program will perform supervised sessions including resistance training, balance exercises, aerobic activity, and flexibility exercises. The Early Time-Restricted Eating protocol will involve consuming all daily food intake within an early daytime window while maintaining usual dietary quality and adequate energy and nutrient intake.\n\nThe main outcomes of the study include changes in bone mineral density, gait performance, balance, and fall risk. These outcomes will be measured at baseline and after the intervention period.\n\nThis study will provide evidence on whether combining early time-restricted eating with structured exercise can improve musculoskeletal health and functional ability, and reduce fall risk in older adults.",[97,98,99,100,101],"Nutrition","Health and Wellbeing","Aging","Time Restricted Eating","Bone Health",[100,103,104,105,18],"Exercise Program","Bone Mineral Density","Gait","NOT_YET_RECRUITING","2026-07-09",{"date":109,"type":110},"2026-07-13","ACTUAL",{"date":112,"type":91},"2026-06-15",{"date":114,"type":91},"2026-12-30",{"name":5,"class":6},1]